Recruiting

Diabetes

Sponsor:

Johns Hopkins Bloomberg School of Public Health

Code:

NCT06770673

Conditions

Diabetes

Eligibility Criteria

Sex: All

Age: 10+

Healthy Volunteers: Not accepted

Interventions

TOD Great Plains

Waitlist Standard of Care

Study Details

Brief summary:

The goal of this research is to evaluate a scientifically rigorous diabetes intervention, Together Overcoming Diabetes (TOD), that has been tailored to address the unique underlying risk and protective factors and social determinants of diabetes among American Indian/Alaska Native (AI/AN) populations.

Conditions

Diabetes

Study ID

NCT06770673

Start date

Mar 11, 2025

Status verified date

Jan, 2026

Completion date

Oct, 2028

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10+

Healthy Volunteers: Not accepted

Inclusion Criteria - Adult Index Participants:

  • 18 years and older
  • Self-identifies as American Indian or Alaska Native
  • Rapid City-based participants who reside within 1 hour transportation range of the Oyate Health Center
  • Verification from a health provider to confirm Type 2 Diabetes diagnosis by laboratory test.
  • Caregiver to a 10- to 25-year-old in their home at the time of screening.
  • Willing to complete all implementation and follow-up assessments.
  • Willing to be randomized for the intervention.

Exclusion Criteria - Adult Index Participants:

  • Inability to participate in full intervention or evaluation (e.g., planned move, residential treatment, etc.)
  • Willing to serve as 'support person' for the adult participant.
  • Has a circumstance that might impact successful participation based on provider judgment considering instances where diabetes control can become more difficult with advanced disease or special conditions including: pregnant, nursing, or planning to become pregnant, end-stage renal disease on dialysis, diabetes due to secondary causes such as Cushing's or Cystic Fibrosis, or any condition that may inhibit participation

Inclusion Criteria - Youth Support Participants:

  • Between 10 years and 25 years old
  • Self-identifies as American Indian or Alaska Native.
  • Willing to serve as 'support person' for the adult participant.
  • Willing to complete all implementation and follow-up assessments.
  • Willing to be randomized for the intervention.

Exclusion Criteria - Youth Support Participants:

  • Cognitively or visually impaired
  • Youth in foster care (due to potential mobility of foster youth).

Study Design

Enrollment

140 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Together Overcoming Diabetes Intervention

Together Overcoming Diabetes curriculum adapted for Lakota caregivers and the caregivers families

placebo comparator: Waitlist Standard of Care

Participants who are waitlisted to receive the TOD intervention will receive Standard of Care.

Interventions

TOD Great Plains

The adapted TOD intervention is rooted in the original TOD structure, delivery system, and home-visiting teaching schedule. Local enhancements include intervention topics and activities to address local adult caregivers' diabetes management and to promote families' modifiable risk and protective factors targeted by this proposal and informed by the Wicozani wellness concept and measurement. The TOD intervention includes targeted content taught approximately bi-weekly by family health coaches over a 16-week period.

Waitlist Standard of Care

Participants who are waitlisted to receive the TOD intervention will receive Standard of Care.

Primary outcome measure

  • Glycated hemoglobin (HbA1c) [ Time Frame: Baseline, 3 months, 6 months, and 12 months ]

Central Contacts and Locations

Central contacts

Courtney Claussen, PhD

605-200-0043cclauss1@jh.edu

Locations

Center for Indigenous Health - Great Plains Hub

Recruiting

Rapid City, South Dakota, United States, 57701

More Information

Sponsor

Johns Hopkins Bloomberg School of Public Health

Last update posted

Jan 23, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins Bloomberg School of Public Health on 2026-01-23.